Covidien plc (Covidien), a company focusing in medical devices, imaging solutions, pharmaceuticals and medical supplies, has received US Food and Drug Administration(FDA) approval for DuraSeal spine sealant. Covidien expects to launch DuraSeal spine sealant in the next few weeks.
DuraSeal spine sealant has been shown in a US pivotal study to deliver an intra-operative watertight seal 100% of the time. In the same study, commonly used sealing methods achieved an intra-operative watertight seal only 64% of the time. The remaining patients were treated with additional products and or techniques to achieve a watertight seal.
DuraSeal continues Covidien’s dedication to scientific, evidence-based innovation that improves patient outcomes, said Dr. Michael Tarnoff, chief medical affairs officer, Surgical Devices, Covidien.
There’s a critical need to resolve cerebrospinal fluid leaks within the OR. We cannot continue with the procedure until we’ve dealt with the leak, said Dr. Neill Wright, Associate Professor, Neurological & Orthopedic Surgery, Washington University School of Medicine.
The DuraSeal spine sealant is designed to be a quicker solution than conventional sealing methods, for surgeons who are faced with a dural tear.
The fast-acting, self-contained sealant gives surgeons the only FDA-approved, easy-to-use solution for sutured dural tears, which occur in nearly 10% of all spinal surgeries.
The DuraSeal spinal sealant only takes two minutes to prepare for use and three seconds to set, so surgeons can quickly complete an intra-operative dural seal.